Friday, January 27, 2023

When Will Over The Counter Hearing Aids Be Available

Will This Make Hearing Aids Cost Less

FDA finalizes rule to make hearing aids available over the counter

Not necessarily. On average, a pair of prescription hearing aids costs over $4,000. For good quality hearing aids, a large part of this cost comes from the components and required research and development. Another large slice is associated with obtaining the hearing aids from, and having them fitted by, an audiologist.

You also cant rely on your health insurance to pick up the costs either. There is no hearing aid coverage through Medicare parts A or B. Private health insurance may also require additional costs to buy hearing aids or set limits on coverage. Check your state regulations, though, as some require coverage but have spending limits and may be restricted to specific age groups.

Even though these new guidelines establish a process by which over-the-counter hearing aids can be sold, the need for an audiologist and prescription is the only part of the process being removed. Testing for these products must still happen to an intense degree for full FDA approval, and those tests dont come cheap. So, while hearing aid costs may decrease somewhat with these new laws in place, users shouldnt expect a night-and-day difference now that the changes have gone into effect.

How Much Cheaper Are Over

Michelle Crouch is a contributing writer who has covered health and personal finance for some of the nations top consumer publications. Her work has appeared in Readers Digest, Real Simple, Prevention, The Washington Post and The New York Times.

Editor’s note: This story, originally published Sept. 1, 2022, has been updated to include new information.

More on Hearing

Does Insurance Cover Over

Insurance coverage for OTC hearing aids will be individual and plan specific. If an individual’s insurance plan has hearing aid benefits, they will determine whether or not it can apply to OTC hearing aids. Creed says, “Payment will be on a case-by-case basis and some companies may require a prescription from a provider even though they are OTC.”

Individuals who don’t have hearing aid coverage through their insurance may be able to use FSA funds.

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Are Otc Hearing Aids The Same As Hearing Amplifiers

Personal sound amplification products , also known as hearing amplifiers, can amplify sound in situations or environments where someone without hearing loss may need to hear things more loudly, such as bird-watching or hunting.

PSAPs are not intended to improve hearing in everyday situations or to help those with hearing loss but OTC hearing aids are designed specifically for that purpose. In other words, amplifiers increase the volume of sound, while hearing aids improve the quality and volume of sound based on a persons specific type and degree of hearing loss.

PSAPs
Yes

Otc Hearing Aids Will Likely Come With Challenges

Cheaper, sleeker over

Adjusting for hearing is much more complicated than for vision, making it challenging for people to finely tune their own hearing devices.

With vision, youre looking at one variable: Is vision clear or blurry? When we test , we test every frequency, from 125 hertz to 8 kilohertz, that allows us to appreciate everything from music to speech, Kim explains.

When fitting someone for a hearing aid, you then have to set each frequencys maximum comfort level and maximum threshold level and fine-tune it for each individuals hearing loss patterns and even ear canal shape.

Beyond the complex tuning process, the process of hearing loss is typically so gradual that the brain adapts to a new reduced input. Living with this new normal means that adjusting a hearing aid to proper levels can be nearly impossible for individuals to do on their own.

When we do a good job bringing back sound across frequency and across input levels, the person will not like the sound for a week or so until the brain adapts to this new normal, Palmer says.

If you had the person do this themselves or asked them how things sounded, you would slowly tune the hearing aid to mimic the hearing loss because this is what the person considers normal until they are exposed to the correct levels of sound, Palmer states.

Difficulties self-tuning are problematic in part because individuals might think that hearing aids just arent helpful for them and stop seeking additional medical care, Kim expresses.

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When Will Otc Hearing Aids Become Available For Sale

Even with latest order issued by President Biden, the new OTC category of hearing aids will likely not be available to consumers for some time.

The practicability to act on these considerations will take effect upon the FDA releasing its final draft, commented Dr. Amlani. The final draft is expected within the next 18 months, after the completion of a public comment period and re-review of the guidelines.

There have been many calls on the FDA to release the much delayed OTC draft regulation. We hope that President Bidens Executive Order will result in definitive action by the FDA within 120 days. Once the draft regulation is released, we anticipate a public comment period, followed by further FDA review. It could take up to nine months or more for the final regulation to be released. Effectively, OTC hearings aids are not likely to be available to consumers until mid to late 2023.

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Otc Hearing Aids May Eventually Have New Designs And Look Different From Prescription Hearing Aids

  • Over-the-counter hearing aids: At first, OTC devices may largely resemble the simplest prescription hearing aids. But experts say allowing manufacturers to market directly to consumers will foster competition and spur innovation in hearing aid design.

Nicholas Reed, an audiologist at Johns Hopkins University Bloomberg School of Public Health and co-author of the AARPs new Hearing Loss for Dummies, predicts that allowing over-the-counter devices will prompt some crazy technology changes related to what a hearing aid looks like in the next 10 or 20 years.

  • Prescription hearing aids: If you get a prescription pair, you will have a range of options when it comes to design, including behind-the-ear, in-the-ear and discreet custom styles. With the help of an audiologist, you will be able to try out different designs for comfort and fit.

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The Basics: Hearing Aids Versus Amplification Products

There are various types of hearing aids that largely work in the same way. Whether the style is behind the ear or in the ear canal, they amplify sounds to make them louder. They also help filter out certain types of noise. “All hearing aids use a combination of signal processing and directional microphones to filter out some unwanted noise and to improve our ability to hear sounds,” says Dr. Naples.

Don’t confuse prescription or OTC hearing aids with personal sound amplification products sold at most drug stores. Such products merely amplify nearby sounds. Theyre not tailored to an individuals hearing loss, and arent regulated by the FDA or intended to treat hearing loss.

“PSAPs are a great alternative for people who only experience difficulties in specific situations, like listening to the TV, says Dr. Naples.”

How We Tested Over

Hearing aids now available over the counter

Our testing process consisted of both objective and subjective testing and took many months to complete. For the objective testing, we focused on measuring each devices maximum gain and its frequency response .

We were surprised to learn from our sources that, despite the fact that PSAPs and hearables have a legally limited amount of gain based on ANSI standards, there isnt an FDA oversight board that tests the efficacy or safety of any hearing-augmentation device, including hearing aids. The entire industry essentially polices itself by relying on doctors and wearers to flag deviations or return the things they buy. Because we know the potential risks of listening at too-loud volume levels, we wanted to find out whether any of the devices that we called in would fall outside the ANSI gain specifications.

Senior staff writer Brent Butterworth and I met with Linda Kozma-Spytek, senior research audiologist at the Technology Access Program at Gallaudet University, to discuss what we might be able to reasonably measure. Brent used his GRAS Model 43AG ear/cheek simulator with a KB5000 simulated pinna, in conjunction with an Audiomatica Clio 12 audio analyzer and TrueRTA software, to analyze the frequency response and the gain of our test samples. We then compared these numbers to the ANSI PSAP or hearing-aid standards to check that they fell within guidelines.

Heres a quick snapshot of our panelists:

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Will I Need A Hearing Test To Get An Otc Hearing Aid

Traditionally, people have their hearing tested by a certified audiologist trained to configure hearing aids based on a persons specific hearing loss. The process is similar to getting prescription glasses.

Hearing tests measure how loud a sound needs to be for you to hear it clearly. People with normal hearing can identify sounds less than 25 decibels . Mild to moderate hearing loss is in the 26 dB to 55 dB range. A person with mild hearing loss may hear certain speech sounds, but find softer sounds hard to hear. Someone with moderate hearing loss may have difficulty hearing speech when another person talks at a normal level. Hearing loss related to age or other conditions may affect one or both ears.

OTC hearing aids dont require a hearing test by an audiologist. However, these devices can only treat mild to moderate hearing loss. “If you have severe or profound hearing loss, you still need to see an audiologist for a full exam,” says Dr. Naples.

Hearing Aids Are Now Available Over The Counter What To Know Before Buying One

On Oct. 17, hearing aids approved by the U.S. Food and Drug Administration became available over the counter for the first time, for potentially thousands of dollars less than prescription hearing aids. Many experts are hopeful that opening the market up will spur the creation of innovative new devices, bring down costs, and encourage hearing-aid use in a country where only a fraction of older adults who are hard of hearing use hearing aids.

What do these expanded options mean for people who are thinking about buying a hearing aid? For now, experts say theres still a lot we dont knowincluding which devices will be announced in the coming months and how much prices may fluctuate on the new market. However, over-the-counter hearing aids could make a big difference in your life if you have mild or moderate hearing loss. Heres what you need to know.

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What Is The Difference Between Otc And Prescription Hearing Aids

Prescription hearing aids require an in-person hearing exam, a prescription, and purchase of the hearing aids through a hearing care clinic. You also need to have the devices fitted and programmed in the clinic, which may be bundled into the up-front cost of your hearing aids or charged separately.

OTC hearing aids operate with similar technology to prescription hearing aids, but the buying process and customer experience are different. With OTC hearing aids, you can take a hearing test in-person or online, buy them without a prescription directly from the manufacturer or from a retailer that sells hearing aids, and fit and adjust them at home.

Unlike prescription hearing aids, OTC hearing aids are only meant to treat mild to moderate hearing loss in people 18 years and older. Prescription hearing aids are available for people of all ages, and for all types and degrees of hearing loss.

Otc Hearing Aids Vs Psaps

Best Over The Counter Hearing Aids in 2021

Although OTC hearing aids are not approved by the FDA for more significant hearing loss, they are true hearing aids that use the same technology as prescription hearing aids, according to the National Institute on Deafness and Other Communication Disorders .6

On the other hand, personal sound amplification products , also known as hearing amplifiers or sound amplifiers, are not meant to be used as a treatment for hearing loss, nor are they regulated by the FDA.7

Hearing aids amplify only certain sounds based on your hearing profile, but PSAPs amplify all sounds equally. People with normal hearing often use PSAPs for recreational purposes, such as birdwatching, to make all sounds in the environment louder.

The FDA also points out the following distinction between hearing aids and PSAPs: Because such PSAPs are regulated as consumer electronics and not medical devices, they may be more variable in terms of product quality compared to hearing aids.7

While PSAP devices are useful under some circumstances, if you have hearing loss youll be better supported with a quality pair of hearing aids.

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Hearing Aids Are Now Available Over The Counter Here’s Where To Buy Them

Thanks to a new law, you can now buy hearing aids over-the-counter without a prescription. This law expands access to hearing devices for those with low to moderate hearing loss.

We’ve found over-the-counter hearing devices that are significantly more affordable than prescription hearing aids. We’ve even found some under $100. If you’ve been putting off getting a pair due to cost, check out these budget-friendly hearing aids below.

Top products in this article:

EarCentric EasyCharge rechargeable hearing aids, $199

The U.S. Food and Drug Administration recently created a new category of over-the-counter hearing aids. Those that have perceived mild to moderate hearing loss can purchase these hearing aids without a medical exam, prescription or a fitting from an audiologist. This removes many of the costs and barriers associated with treating hearing loss.

These hearing aids work similarly to prescription hearing aids. They amplify the volume of sounds to help people with hearing loss listen and communicate more easily. If you are unsure whether this type of hearing aid is right for you, Best Buy does offer an online hearing assessment that can help consumers decide whether to shop for OTC hearing aids or see an audiologist to explore prescription options.

Who Are Otc Hearing Aids For

OTC hearing aids are designed for adults 18 years and older who have mild to moderate hearing loss. Candice Ortiz-Hawkins, doctor of audiology at Capital Institute of Hearing and Balance in Silver Spring, Maryland,offered guidance for people wondering if their hearing loss fits into that range. If a person requires speech to be loud, even in quiet environments, or has great difficulty participating in conversations or hearing in noisy environments, their hearing loss is likely more severe than the permissible range for OTC hearing aids to work, said Ortiz-Hawkins.

Ortiz-Hawkins noted certain instances in which you should seek the help of a doctor, audiologist, or other hearing care professional for an in-person evaluation. The FDA recommends a hearing exam by a licensed medical professional for people with the following symptoms:8

  • Injury to or deformity of the ear
  • Fluid, pus, or blood coming from one or both ears
  • Sudden or fluctuating hearing loss
  • Better hearing in one ear than the other
  • Ringing or buzzing in one or both ears
  • Constant pain in one or both ears
  • Vertigo or dizziness
  • A full or plugged feeling in the ear

An in-person evaluation is the only way to diagnose and treat an underlying medical condition.

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Best Invisible Fit: Eargo

  • Price per pair: $1,450$2,950
  • Hearing aid style: Completely-in-canal
  • Bluetooth and mobile app capabilities: Yes
  • Adjustment: App, tapping the hearing aid, or remote assistance
  • Standard warranty: 1 year or 2 years
  • Financing available: Yes

Eargo sells four models of completely-in-canal hearing aids that are so small you can barely see them in your ear, making this brand our choice for Best Invisible Fit.

Our Reviews Team liked the variety of tips and domes that Eargo provided with the hearing aids we tested , allowing each person to find the fit that was most comfortable for them.

Figure 1 Eargo tips and domes unboxed by our Reviews Team

Our Reviews Team talked with Brian Murray, a hearing instrument specialist in Raleigh, North Carolina, and he pointed out that two styles and sizes of tips may not fit every ear canal. He also cautioned that people with certain types or degrees of hearing loss need a BTE or RIC-style hearing aid rather than an ITE or CIC style. For more information on hearing aid styles, read our hearing aids buyers guide.

All Eargo devices are rechargeable, so you wont have to worry about changing batteries. This can also save money over time by removing the cost of replacement disposable batteries.

Other than the battery type, each Eargo model has its own set of unique features, which are outlined in Table 3.

Table 4 Comparison Of Lexie Hearing Aids

Hearing aids now available over the counter

Lexie Lumen

  • Price per pair: $1,898$3,398
  • Hearing aid style: Receiver-in-canal, behind-the-ear, in-the-canal
  • Rechargeable battery: Yes
  • Bluetooth and mobile app capabilities: Yes
  • Adjustment: App or buttons on hearing aid
  • Standard warranty: 2 years
  • Financing available: Yes

While increased competition among OTC hearing aid manufacturers is expected to drive prices down, hearing aids are still an expensive purchase. For many people, financing can mean the difference between treating their hearing loss and having to wait.

Audicus offers four models of OTC hearing aids along with multiple financing options, making it our choice for the Most Financing Options. And while Audicus offers more financing options than any other company on this list, its worth noting that its hearing aids do have a below-average battery life at 18 hourswhich is lower than half the companies on this list.

Like MDHearing, Audicus offers a range of devices with different features and prices. See Table 5 to compare the different models.

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